MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS; PRIMARY CONSOLE WITH ADULT FLOW PROBE

Model Number 201-90401

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is reporting the primary console.The motor is reported under medwatch mfr report # 2916596-2018-04455.The device is expected to be returned for analysis.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that an s3 alert occurred.The battery was calibrated; the first time failed while the second time passed.During mock loop testing, an m2 error occurred.No additional information was provided.

Manufacturer Narrative

The centrimag console is not a single-use device.The approximate age as calculated from the manufacture date was 5 years and 1 month.Manufacturer's investigation conclusions: the reported event could not be confirmed through the evaluation of the returned centrimag console and a root cause could not conclusively be determined through this evaluation.The returned centrimag console was inspected upon receipt and revealed scratches to the housing, a dent in one of the rear edges, and a crack in the front overlay.The console was then cleaned.The console was tested on a mock loop.The motor cable was bent bi-directionally at its whole length and no alarms were reproduced during 2 days of system operation.The battery maintenance procedure was performed twice and the console passed.No faults were reproduced during this maintenance.The returned system operated as intended.The console was then opened for internal inspection which revealed dust and dirt particles in the interior of the console.All internal components appeared unremarkable.The console¿s damaged front overlay was replaced and the bent housing edge was bent back into the correct position.The console¿s software was updated to the current revision.A root cause for the reported event could not be determined through the evaluation of the returned console.The console will now be returned to the customer.The centrimag system operating manual states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support".No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
• Type of Device: PRIMARY CONSOLE WITH ADULT FLOW PROBE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7976604
• MDR Text Key: 124839253
• Report Number: 2916596-2018-04454
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90401
• Device Catalogue Number: 201-90401
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1